This Is MS Multiple Sclerosis Community: Knowledge & Support

Welcome to the world's leading forum on Multiple Sclerosis research, support, and knowledge. For over 10 years, This is MS has provided an unbiased community dedicated to Multiple Sclerosis patients, caregivers, and affected loved ones.

Sudden death “smacks of being cardiovascular in nature,” Anderson wrote, adding that the possibility of a temporary slowdown in heart rate after patients start treatment with Gilenya is part of the reason for a recommendation for monitoring in a doctor’s office after treatment begins.

I had heard about the strong immune system effects of Gilenya, which could be as bad or worse than Tysabri, but was unaware that there were cardiovascular safety issues as well. Tread carefully....

Advertisement

Newer MS drugs tout efficiency and performance in derailing MS progression and even offering glimpses of neuroprotection for the patient, which far exceed the existing CRAB drugs, but at what cost? Total immune compromise? Correct me if I'm wrong but, isn't one of the newer MS drugs being researched is also indicated for HIV infection?

Cece wrote:...was unaware that there were cardiovascular safety issues as well. Tread carefully....

Before you start treatment, they do an ECG, and then when you actually take your first dose, you are supervised and they monitor your heart rate every hour for 6 hours. Most people are not noticeably effected, however I was suprised to read in the information supplied by the makers, that a lowered heart rate response normally returns to normal within a month. What, a month! Mine supposedly dipped on one of the hourly measurements, but only a little, and was back the next hour.

Total immune compromise?

Gilenya is far from this, but definitely has some possibly severe side effects. However, for me personally, it has FAAAAR less side effects than Rebif (which was unbearable for me) and although I can not say Gilenya has improved my MS condition, it certainly did not make it worse like it got when I was on Rebif.

And I think this news has already been posted elsewhere on this forum, but we are still awaiting news as to what the patient actually died of?

There is little information about the deceased although the article certainly brings up the profit/loss potential:

Anderson wrote. He rates Novartis’s shares “outperform” and estimates that by 2015 Gilenya sales will reach $1.4 billion, about 2 percent of the Swiss company’s revenue.

Gilenya is certainly not an option for me as I've had six retinal detachments (and surgeries). Since retinal detachment is one of the potential side effects of Gilenya, I agree with you completely : extreme caution is indicated. Blindness is not something I'm willing to risk for a drug that is not a cure.

More concerning, if profits over a 3 - 4 year period are expected to exceed over a billion dollars for this and other drugs, what incentive do medical researchers have to cure MS?

selkie wrote:Thanks for posting this Cece - if it was posted before, I missed it.

Gilenya is certainly not an option for me as I've had six retinal detachments (and surgeries). Since retinal detachment is one of the potential side effects of Gilenya, I agree with you completely : extreme caution is indicated. Blindness is not something I'm willing to risk for a drug that is not a cure.

Yes, Squiffy posted this news item the other day on the Gilenya Forum here under the title "Novartis investigating death possibly linked to Gilenya" Here's the link:gilenya-f43/topic18724.html

The cool thing about Squiffy's posts is that the links to articles in them go directly to the Multiple Sclerosis Resource Centre (MSRC) in the UK, and when you get to the site you have a whole stream of Gilenya news articles to scroll down through. Each MS med, etc., has its own page of articles there. Cool.

Another point I wanted to make for you, selkie, is that I don't think "retinal detachment" is one of Gilenya's side effects, but you may be thinking about macular edema (swelling of the retina). If I were you I would still be very concerned about a med that could potentially affect my vision, though. Six retinal detachments? Yikes! Hope you're doing okay now.

I posted on Squiffy's macular edema thread in the Gilenya Forum a while back, since I was diagnosed with ME many years ago (30?). Here's a link to that thread:"Gilenya may increase risk of macular edema in some patients"

Yeah, my history of macular edema is one of the (many) reasons I'm going to have to decline my neuro's latest suggestion that I take Gilenya. My background also hits a few of the other main Warnings and Precautions listed in the prescribing information for Gilenya, which my neuro didn't notice.

From the drug info -

The Warnings and Precautions list 7 items including – 1. Cardiac Disorders (I have a family history of heart attacks.)2. Macular Edema (I have a personal history of ME.)3. Increase in blood pressure ( I have poorly controlled HBP.)

Drug Interactions: I take 1 of them – a beta blocker (I was taking 2 of the meds in the precautions at the time she suggested Gilenya, but just dropped the 2nd one.)

If you scroll down to the bottom of Gilenya's home page you can click on the "Full Prescribing Information" as well as the "Patient Medication Guide." I have them both printed out right next to me with sections highlighted from when I was researching meds at my neuro's request.

I ended up producing a 4-page treatise on the reasons I'm not a good candidate for any of the meds at this time and sent it to my neuro. I hope Gilenya turns out to be a good option for others, but this sort of surprising news is why I told her that I'm definitely not going to be first in line for such a new, unproven med - especially with my other medical conditions.

Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)

Thanks euphoniaa for the links & correction. However in my case any disorder of the retina could lead me to another detachment. So it's definitely a concern for any MS patient who has had any disorder involving their retinas. In fact there are even certain yoga positions my eye doctor warned me to avoid as even an increased blood flow to the head puts strain on the retinas. So potential candidates for Gilenya should investigate carefully all the risks.

Will check out the links on the other meds you posted though I'm on no DMD as I'm SP & believe the disease w/ run its course with or without adding drugs w/serious side effects to the mix. I am however on several meds for my symptoms. Of course I'm still hoping they'll find a cure for us.

selkie wrote:Thanks euphoniaa for the links & correction. However in my case any disorder of the retina could lead me to another detachment. So it's definitely a concern for any MS patient who has had any disorder involving their retinas. In fact there are even certain yoga positions my eye doctor warned me to avoid as even an increased blood flow to the head puts strain on the retinas. So potential candidates for Gilenya should investigate carefully all the risks.

Will check out the links on the other meds you posted though I'm on no DMD as I'm SP & believe the disease w/ run its course with or without adding drugs w/serious side effects to the mix. I am however on several meds for my symptoms. Of course I'm still hoping they'll find a cure for us.

Hi again selkie,

FYI - the 3 links I posted are all Gilenya links. The first 2 are to threads in the Gilenya forum and the last one is just to the Gilenya website in case people want the entire prescibing info.

One of the many, many reasons I refused DMDs myself is that, after 38 years of MS, I have no recognizable relapses and only slo-o-o-o-w progression for as long as I can remember. I don't think there's any way I'm still RR, even though my neuro keeps listing me that way, and, in fact, I'm not positive I can identify an obvious MS relapse in my entire life due to my other medical problems.

I completely agree with you that there's no point in adding serious side effects to all my other issues at this stage of my life. Like I told my neuro the other day, there's no way I could take a med for every medical condition or symptom I deal with. I hope others learned something about Gilenya from this thread, though.

Sending happy, healthy, holiday wishes to you and all!

Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)

Who is online

This site does not offer, or claim to offer, medical, legal, or professional advice.
All treatment decisions should always be made with the full knowledge of your physicians.
This is MS does not create, endorse, or republish any content.
All postings are the responsibility of the poster. All logos and trademarks in this site are property of their respective owners. All users must respect our rules for intellectual property rights.